Read the summary and watch or listen to the interview here: https://www.crowleylawllc.com/podcasts/navigating-fda-compliance-a-guide-for-life-sciences-startups-with-troy-fugate/
From Lab to Patient, Garage to Market
Troy Fugate Episode
Transcript
Phil: Hello and welcome. Thank you for tuning in to our podcast. We look to bring you leaders in the life sciences and technology who can share their perspectives on developments in this area. How to succeed. Mistakes to avoid and issues to be aware of. In an effort to try to demystify the process of developing technologies into ideas and products and services that can enrich the lives of hopefully thousands or even millions of people.
Phil: Today, I’m delighted to have as my guest, Troy Fugate, Vice President and Co-Founder of Compliance Insight in Cincinnati, Ohio. Troy and his colleagues have done some work in an area that I think life sciences entrepreneurs really need to appreciate and understand better, and that is compliance with FDA and other regulatory regimes. And please stay tuned, because at the end of this session, Troy will give us 1 or 2 key pointers to help you better appreciate the risks and the opportunities in this particular area of technology development.
Phil: Troy, welcome.
Troy: Oh, thank you. Thank you. Glad to be here.
Phil: Well, please tell us a little bit about your background and the pathway that led you to where you are today.
Troy: I tell you my background, it’s like that starting of the Star Wars movie on a galaxy far, far away a long time ago. So that’s really where I started in this, really humbly as a quality engineer and worked my way through quality assurance.
Troy: And then worked really side by side with the FDA during some significant regulatory issues back long ago. And that’s really where I honed my skills of focusing on compliance and understanding the concepts with people and how they make decisions from that really worked through industry and met my current business partner, Pfizer. And at that point we decided that we would go out on our own.
Troy: And she started the company in 2000 and then 2001 right behind her. I went on as her partner. That’s sort of how I got to where I am today.
Phil: Well, that makes you an entrepreneur and innovator and startup executive in your own right. It’s quite a story.
Troy: Thank you.
Phil: What sort of issues take care of most of your time these days as you work with your clients?
Troy: We have two real buckets of things I could look at. One is the remediation type of work. So the activities of remediating people have found themselves into some regulatory problems. The other one is really a lot of startup companies from concept to working in academia, benchtop, and how they are able to get that product from that concept or early stage to a commercialized material.
Troy: And that takes up a large amount of planning, coaching, mentoring and just laying out the regulatory pathway for them.
Phil: What are some of the key problems that you’ve seen in life sciences startups that they should be aware of?
Troy: Various things. If you’re starting up, it’s really understanding the runway. People always speak to the cash runway. How much money do we have to keep the company going?
Troy: It’s the same for compliance. You have to understand what it’s going to take. Where are the milestones? Where do you need to start implementing certain phases of GMP? There’s always some level of it. But you have to be able to understand that pathway. I tell you, the planning is probably one of the bigger items that we see constantly.
Troy: And also working with farming it out, when these people start up their new, they go out and they look for a partner to make the product a CDMO. And really selecting the right CDMO for you is going to be a game changer. You will either have a partner, or you will have a transactional relationship where you will be nickel and dime to death for everything, and they really don’t have your best interest in mind.
Troy: You really take some time to develop that relationship and find the right partner for you in your product and in the context of your company and your finances.
Phil: I might just interject here, Troy, for some of our audience who are not experts in this area of GMP’s or Good Manufacturing practices. There’s some of the regulations that the FDA looks to when you’re manufacturing product. A CDMO is a contract development and manufacturing organization. And as Troy was speaking, he was pointing out the fact that many startups delegate out to third party vendors, some or in some cases, almost all of the development process. And so it’s necessary to have somebody with the capability to actually make the product and create the files that are necessary.
Phil: And that’s what Troy is speaking about when he speaks about GMP and CDMO. And then you mentioned something about the partnership between the company and the CDMO in order to ensure that alignment and what happens, Troy, in your experience when the company simply views their CDMO as just another vendor that they’re going to use before they get to the great Promised Land?
Troy: Well, it typically is a problematic relationship, ranging from adversarial to nickel and diming you to death for things. It really is a problem when you get to a point where you don’t have that partnership, where you’re both in the same boat, you’re both have the same vision. You understand each other. You relate to each other. You have empathy.
Troy: All of the things you can think of really being a good partner to a person from, say, you and I feel to a company to company. You have to look at them as people and treat them as people. And it’s a two way street, so it can lead to very long, problematic issues that cost lots of money, time, effort and in some cases it can derail the product.
Troy: You can get to a point where you’re just not able to progress with your partner one way or in the other, and it breaks down.
Phil: Well, you know, it’s very interesting from your perspective because you see this right on the front lines, Troy, that even though we’re talking about high technology biotechnology the life sciences, it seems like the human dimension, the ability to communicate, the ability to work constructively with other people and to work out your differences in a productive way, is also very important to establishing the relationship that you need to get all of that high technology done in a way that is compliant with applicable regulations.
Troy: Yes.
Phil: Now, when companies are thinking about compliance, of course, they think typically of a global marketplace because of the marketplace for pharmaceutical products and biotech products in the life sciences are typically international. And I was wondering from your perspective, are there material differences in the way that the United States, the European Union, Japan, China view, regulatory affairs? Are there some common themes or some places that are safe harbor where if you comply with one set of regulations, you’re more or less set for the other regulatory authorities?
Troy: Differences between the different regulatory agencies is not much. There are nuances. Let’s say that the US typically focuses on data documentation. Europeans will look at the maturity of a system to Japanese. You mentioned them. They look at risk. They’re very risk averse. So it really all boils down to one factor. And having dealt with all these different regulatory agencies over the years, it gets down to one thing that you have to be able to demonstrate proof to show that one thing is control.
Troy: That you can there nuances about it. There are things that you can say some regulatory agency may focus on more than others, but when it gets down to it, it’s the concept to control. Are you in a state of control? How do you know you’re in a state of control? How do you get back into control when you’re out of control? I’d say you have to look at usually the U.S. FDA is a key game player in all of this.
Troy: And so if you comply with the U.S., FDA, and the regulations, as you mentioned, the GMP’s, the Code of Federal Regulation, the CFR says you’ll go a long way to be in complying with a lot of other nations as far as that goes. But when you get to that point and you are looking at an international market, jurisdictional control of, you see, is going to be a key player in this, and it would pay you to go through and look at any of the nuances of those jurisdictions and understand what are the things you have to do, say, in Europe, you have to have a QP or a qualified person and that’s something that in U.S. you don’t have to have. So there are some changes. But really, ultimately it all boils down to being in a state of control.
Phil: Now, I would imagine that that starts with a culture which sometimes it may be difficult to inculcate into the startup culture, where people are trying things and doing things in a very innovative way. And it seems that that could be inconsistent with what you’re saying that is that you have control of the system and a focus on another factor, which I know you’re very well steeped in, and that is quality systems and the mentality about that.
Phil: And how do you find that startups can incorporate that into their thinking early in the process?
Troy: I tell you, it’s important to understand that the concepts that control the concepts of the GMP early phase is not a full blown FDA GMP system of everything in control. It’s understanding the level of control. There’s a phrase that goes around the phase appropriate GMP’s, and it’s something that companies struggle with to understand what is phase appropriate, where should we be.
Troy: And it’s not really something a program that you can just buy a binder and say, oh, this is what we have to do. Yes. But you have to be able to think about it. It’s risk. What are the levels of risk? What do you have to do to be in a state of control? I tell you, if I had a dollar for every time a development or R&D person has come to me saying, oh, we don’t need any of that GMP stuff, we’re in R&D.
Troy: And I say up, well, you obviously then make your product in buckets out in the parking lot. And they’d say, no, if we don’t do that, I say, oh, okay, well then you probably write down your notes on post-it notes with pencil or crayons and you throw away some things. You only keep the stuff you really want. And they’re like, oh, no, we don’t do that.
Troy: I’m like, okay, well, you’ve got GMP already. It’s just how you think about GMP. Where is it that you want to control? I remember a point in time going into companies that were having problems with their price products being made and going back to R&D, looking at it and saying you didn’t really make it that well. Your data is all over the place.
Troy: It’s inconsistent. So you push this process over to operations that they couldn’t make. It was really a philosophy of, well, we’ve developed it. You figure out how to really make it in mass. And and that was a wrong way of doing it. So I can tell you that’s, that’s a word of caution with people who are thinking, I don’t have to have this up front.
Troy: It really is something that you should have a vision of. What is it that I’m trying to do? Ultimately, it is to make a product that goes from the lab to the patient, from the garage to the market. It really is that. It is. How do you do that? And it’s not just blindly rushing forward with anything you can.
Troy: Using expired materials that production gave you to do your R&D work with or old equipment, those are the wrong concepts. So you really must have a vision with where is it? I want to control it. How do I do that? And where are those milestones? As I get farther and farther along in the process, from development to talks to phase one to phase three, all of the regulatory work along that line and have that mapped out that will be so fundamentally valuable to you at this point that I can’t tell you just the companies that have such problems dealing with it at a later stage than those that deal with it upfront.
Phil: Well, that’s great, Troy, I just like to take a minute here to introduce our audience to Crowley Law. We are a boutique law firm that is passionate about helping lifesciences and other technology entrepreneurs avoid being taken advantage of as they pursue their dreams. I’m a former research physicist. I did my work in superconductivity, and I know how hard it is to create new knowledge.
Phil: And as a corporate lawyer, I know how difficult it is to take that new knowledge, even great ideas, and bring it successfully to the marketplace to create products and services that enrich the lives of thousands or even millions of people. And we are dedicated to helping those innovators succeed. We have a website, Crowley Law llc.com, with a wealth of free resources.
Phil: We have these podcast hosts, and if you go out to Amazon.com, you will find our book, My Book A Void Startup Failure. Learn the top ten Causes of failure for technology startups and how to turn them to your advantage. Because we’re so passionate about helping innovators succeed, that’s why we’re here. So please remember we’re here to help. Troy, I’d like to go back to your review of the relationships that are necessary to be successful.
Phil: And one of the primary relationships is the challenge of dealing with FDA. And I assume that you and your colleagues help companies in that relationship building process. And as I was saying before, even though we’re dealing with high technology, the human dimension, the human relationship is so critical in getting things done. What can you tell our audience to enlighten them about the right way to go about interacting with FDA, as well as other regulatory authorities?
Troy: I can say early on, reach out and develop a relationship with the FDA, and you typically will have a team or a person to which you interact with. And it’s understanding, especially the new products are coming online. These aren’t simple things. There’s a lot of complex SRT in how they’re made, how they’re tested. How do you prove their efficacy?
Troy: How do you prove potency on some of these products? These are very tough questions, and it’s working early on with the FDA. It’s understanding the questions that they might have and working with them. I’ll tell you, I typically tell people it’s an old adage that how do you develop relationships with people? It’s to seek first, to understand and then to be understood.
Troy: So understand where the regulatory agency is coming from. Understand your questions. The why behind the question is more important sometimes in the question itself. And so it is working with them, educating them, training them, inviting them in if they’re so inclined to look at it. And transparency. The agency speaks today quite a bit about transparency, being open, honest and working with them to come to a decision of your product and your process.
Troy: Each of these agencies have their own mission statement. Like the FDA, it is to protect the peoples of the United States. And so that’s ultimately their mantra, their their approach. So just understand that. And as you said, deal with them. It’s the human factor. They’re humans. They put shoes and socks on just like you and I try to every day.
Troy: And they have good days and bad days and so it’s understanding that they are the machines that we’ve, in our mind, built them out to be.
Phil: Well, you’ve had a lot of experience in this area. What role does trust play in establishing that relationship with the regulatory authorities?
Troy: Trust is the foundation. Beyond that, nothing else that I would tell anybody has any merit whatsoever unless they trust me.
Troy: That is ultimately the fundamental building a house on sand. It falls down building a house or a process or a business without trust, it won’t stand because there will always be the doubt in your mind. Now, Ronald Reagan said it best trust but verify. That’s the FDA is approach to this. They will trust you, but they’ll verify it.
Troy: Don’t take it as a conflict or something that you you worry about. That’s their job. It’s to verify what you’re doing. You develop that trust, and that depth of verification will start easing back a bit, because they trust that you are open, you’re honest and your systems in control. If you tell me X and Y, then I will believe X and y.
Phil: You know, we’ve heard a lot about the impact of artificial intelligence in many, many areas of technology, as well as in areas outside of technology. Do you have a view on what the opportunities are for using artificial intelligence to streamline, boost compliance, creating systems and procedures? How does that fit into your thinking when you’re thinking about that?
Troy: Yeah, it’s a very good question. Very timely. My business partner, she is engaged heavily into the AI concepts and working on what does this look like now, three years, five years from now, it is moving rapidly. The FDA themselves are moving to a model of using AI to look at data analytics, being able to understand all of these inputs from industry, other countries, putting it all together and saying, what does this look like?
Troy: I understand that AI is going to be very sharp and able to detect over time, as you put in data in your regulatory filings, if you have something that you filed years ago that does not match what you filed today, and there’s a difference between that data, I will detect that. Now, the dual side of this AI is the out of n data out.
Troy: If it’s bad data in the AI is going to make a bad decision. So all right, how do you deal with that. That’s really getting down to the concepts of what we’ve dealt with now for many years is data integrity. The integrity of the data going into the system has to be fundamentally true and accurate. If it’s not, then the system will make flawed decision, just like a human.
Troy: If if I told you was raining outside, you would put on a raincoat and walk outside and it’s not raining, it’s sorting out. And you say, Troy, why did you tell me that? It was like, well, I was looking at this app that told me it was raining, and so I gave you bad data. So that’s the thing we have to think of with AI.
Phil: Well, Troy, you’ve been a prolific author. I’ve looked out at your LinkedIn profile and you’ve written many articles and several books. You know what inspired you to want to share your knowledge in those media?
Troy: I tell you, Phil, I was listening to you speak about your company and your passion in helping people. That really resonates with me. It truly is to help people to say, hey, if I took 30 years, 30 plus years now of experience and knowledge, and I boiled it down into a book that you could read in a week, would that be of value to you?
Troy: And most people are like, yes, I don’t want to have to go through 30 years of the blood, sweat and tears and scars that you’ve had, the gray hair that you and I both have, you know, it’s built on that experience. So it was to go out there and say, hey, think about these things, understand the work that you need to do and how you need to think going into this.
Troy: A lot of people come back telling me, wow, this is really good to your book. I made a note. I’m going to go out and look at your book. It is to help people to to prevent them from doing the mistakes that you and I have seen and battled to remediate over the years.
Phil: Well, Troy, now, what I’d like to do for audience is ask you to give them 1 or 2 key concepts that they can use in their businesses and their thinking about their scientific developments that can put them on the pathway to regulatory compliance, or at least avoid some common problems that you’ve seen companies experience.
Troy: I tell you, I give you two. Number one is, as you’re building your product in the parallel paths, be building your quality system compliance, regulatory, whatever you want to call it. It’s just to not rush so far ahead that you’re you’re looking at the product without understanding what you need to have with the compliance aspect. Number two is to have a vision of your product.
Troy: Where do you want to take it? A lot of times I’m approached, were approached by companies that are smaller developments. They have these concepts. And the first question I ask them is, what do you want to do with this? It’s like being a kid, you know, what do you want to be when you grow up? So when the product is going forward, what do you want to do with it?
Troy: Do you really want to take it to commercialization and understanding all of the challenges, all of the work and effort that has to go in to make that? Do you want to get it to a point where you sell it? Do you want to get to a point where you partner with someone with it, where along the line is that occur?
Troy: Really? I tell you, that will help out companies significantly, both from planning regulatory compliance wise to the product to reaching out to partners and the financial aspect of it. What does it take if you’re looking for financial assistance, it goes a long way to be able to go out and say, I’ve mapped this out, here is my plan.
Troy: This is what I want to do with it. And it helps significantly if you do those two things, you might get it the other side of this whole thing and not have like, you know, you know, gray hair, white hair and have a successful product and, and say, yeah, you know, that was fun. I want to do that again.
Phil: That’s great. Troy, these are some great insights. How can people get Ahold of you? Learn more about your company?
Troy: Well, I’ll tell you what. Best way to learn more about the company, go to our website. It’s, WW compliance-insight.com. And from there you can see a lot of articles, blogs, things that we do for myself, you can always just reach out to me via email as T fugate@compliance-insight.com.
Troy: More than happy to to help people like you I. I have a great passion. I, I really enjoy seeing people succeed and sometimes it’s from the depths of GMP hell, as I would say, and being able to pull them out of that and see them succeed, that that is a significant enjoyment in my career.
Phil: Very good. Troy, thank you so much for sharing these perspectives on the details of compliance, quality systems and having a quality mentality. And I really take to heart your focus on the need to establish trust in the regulatory authorities in your company so that you have a much clearer communications pathway, transparency and a good working relationship with the regulators. Well, that’s it for today. I hope that our audience has benefited from this particular discussion that I’ve had with Troy. Please, if you found this successful and helpful, subscribe to our podcast and look for future editions. Thanks very much for tuning in.